$100

SMi's 5th Annual Pre-Filled Syringes East Coast 2018 Conference and Exhibition returns to Boston on the 11th and 12th of April 2018. Developing on its annual success, this fifth event in the series will give a unique insight the areas of regulation, manufacturing, emerging trends and innovative solutions to the challenges facing the prefilled industry, helping attendees to secure global success for their devices.

This year’s agenda will feature:

Guidance on the regulations for device development

Human Factors considerations and end-user feedback

Highlight common pitfalls of good manufacturing practice and seek to solve these

Developing on our annual success, this must-attend conference will gather an international audience to discuss and accelerate pre-filled syringe development in all the related sub-fields. Some notable areas of increased attention have been the broader trends for combination products and biologics in the pharmaceutical industry, as well as the move towards digital health and improving patient adherence due to increased self-administration figures. As well as these areas of lucrative opportunity, there are still a number of ongoing challenges that the key-thought leaders are battling to overcome. these include the challenges of chemical compatibility, user safety, high-volume and highly viscous formulation, and non-compliance.

Conference
programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Dhairya Mehta is Associate Director at Shire. After receiving his MS in Aerospace Engineering, Dhairya began his career in the medical device and combination products. Over the past 15 years, Dhairya has successfully delivered a number of projects related to autoinjectors, wearable patch and infusion pumps, reconstitution kits, airway systems, implantable ophthalmic and cardiac rhythm management devices across several organizations such as Medtronic, Abbott, Amgen, Novo Nordisk. Dhairya holds the several US and international patents and other intellectual properties. Most recently, he is leading Digital Health and Device IoT efforts at Shire.

Stephen Barat, Head of Pre-Clinical and Early Clinical Development, ScynexisView Bio

Dr. Stephen A. Barat is the head of pre-clinical research and early development for Scynexis, a biotechnology company focused on the development and commercialization of novel anti-infective treatments for life-threatening infections. He is a member of Scynexis senior management team and has 20+ years of experience in global drug development and registration from large multi-national pharmaceutical companies. Externally, Dr. Barat is a member of the PQRI working group for leachable and extractable for parenteral drug products and a member of the USP expert panel for biocompatibility testing.

Dr. Kashappa Goud Desai is working in the Department of Biopharmaceutical Product Sciences, GlaxoSmithKline, King of Prussia. He has over 10 years of industrial and post-doctoral R&D experience. He earned his BS and MS degrees in Pharmacy, respectively, from Karnatak University and Rajiv Gandhi University of Health Sciences, India. Dr. Desai earned his PhD degree in Biotechnology from Korea University, Republic of Korea.

Dr. Desai is a recipient of several internationally acclaimed awards for his original research contributions. He has published 50 articles in peer-reviewed international journals, authored one book and book chapter, and presented extensively at numerous conferences. He is serving as a reviewer for several international journals in the field of Pharmaceutical Sciences.

There has been a steady increase in the number of high-concentration mAb formulations in ready-to-use pre-filled syringes for subcutaneous administration

10:30 Morning Coffee Sponsored by Zeon

11:00 COP - Technical data update

Toshiro Katayama is the product manager, at Zeon Specialty Materials Inc and responsible in development of Cyclic Olefin Polymer business in the USA. He has over 35 years of various commercial experience, general management, sales and market management, strategic planning, merger and acquisition and purchasing at Gets Bros. & Co Inc (Marmon Group), Union Carbide Corp and Itoh-Chu. He holds Bachelor of Science degree in Mechanical Engineering and Master of Science degree in Structural Engineering from Polytechnic Institute of Brooklyn.

11:40 Drug-device combination product development challenges

Amit Khanolkar has been with Janssen, Pharmaceutical Companies of Johnson & Johnson since 2014 in the Combination Product Center of Excellence. In his current role, Amit is involved in providing leadership and oversight for New Product Development of Janssen Combination Product pipeline.Amit has a background in Medical Device and Combination Product development, with 12 years in R&D in the Medical Device and 4 years in Quality Engineering in the Pharma sector of Johnson & Johnson; where he held successive roles of increasing responsibilities in development as well as commercialization of numerous medical devices and combination products. Amit has actively collaborated across operating companies/sectors of Johnson & Johnson and provided strategic leadership in evaluating product and technology concepts in drug device combinations and convergent technologies.
Prior to Johnson & Johnson, Amit worked in materials and process development of high performance polymer materials for the pharmaceutical/medical device and semiconductor applications.
Amit holds a Master of Science degree in Polymer Engineering from the University of Akron and an MBA from University of Florida. He is a certified Design Excellence Black Belt, Process Excellence Green Belt and also has a certification in Statistical Engineering.

Stephen Barat, Head of Pre-Clinical and Early Clinical Development, ScynexisView Bio

Dr. Stephen A. Barat is the head of pre-clinical research and early development for Scynexis, a biotechnology company focused on the development and commercialization of novel anti-infective treatments for life-threatening infections. He is a member of Scynexis senior management team and has 20+ years of experience in global drug development and registration from large multi-national pharmaceutical companies. Externally, Dr. Barat is a member of the PQRI working group for leachable and extractable for parenteral drug products and a member of the USP expert panel for biocompatibility testing.

Background on leachables from pre-filled syringe drug devices

Whys safety assessment of leachables is required

How leachable issues related to drug product quality can impact safety and efficacy

Best practice recommendations during development

13:00 Networking Lunch Sponsored by Terumo

14:00 Session Reserved for Nemera

Is Global Category Manager – Parenteral of Nemera, a world leader in design and manufacturing of drug delivery device. As Global category manager, he is responsible of Client Intellectual Property projects and Nemera standard technology offering. Prior joining Nemera in 2013, Mr Tisserand worked for Janssen in Strategic marketing in United Kingdom.

Dr. Kashappa Goud Desai is working in the Department of Biopharmaceutical Product Sciences, GlaxoSmithKline, King of Prussia. He has over 10 years of industrial and post-doctoral R&D experience. He earned his BS and MS degrees in Pharmacy, respectively, from Karnatak University and Rajiv Gandhi University of Health Sciences, India. Dr. Desai earned his PhD degree in Biotechnology from Korea University, Republic of Korea.

Dr. Desai is a recipient of several internationally acclaimed awards for his original research contributions. He has published 50 articles in peer-reviewed international journals, authored one book and book chapter, and presented extensively at numerous conferences. He is serving as a reviewer for several international journals in the field of Pharmaceutical Sciences.

Nathan earned his BS in Chemistry and Biochemistry from West Chester University in 2015. He started at GlaxoSmithKline as a contract worker with PPD in 2015. After significant contributions to the Syringe Second source stability study he was hired full time as an Associate Scientist in the BioPharm Product Science department of GSK in 2016.

15:20 The best plastic syringe for biologics

Mr. Shota Arakawa is a researcher of Advanced Business Development Division.
He gained a Diploma in Science in 2007 and a Master Degree of Science in 2009 from Osaka University.
Since April 2009 he has been working for Mitsubishi Gas Chemical Company, Inc.
and in charge of macromolecular science, especially in synthesis of polymers and material development.
Since 2012 he has joined a development team of multilayer plastic vial & syringe for biologics.

OXYCAPT Multilayer Plastic Syringe having Glass-like Oxygen Barrier

Excellent Oxygen Barrier contributes to Stability of Biologics

Very Low Extractables contribute to Stability of Biologics

Good UV Barrier contributes to Stability of Biologics

16:00 Afternoon Tea Sponsored by Zeon

16:30 Session Reserved for Worrell

17:10 Integrating drug-device combination product development

Integrating the design process with methodical pharmaceutical development

QbD and design controls as a paradigm for aligning combination development

Comparison with regulatory guidance on Combination Products and the current state of development of drug device development

Justin Lacombe received a B.S. in Chemical Engineering from Virginia Tech and did his Ph.D. thesis research in fluid mechanics at Rutgers with post-doctoral projects with Sepracor and Albemarle. At Catalent, Justin worked on metered dose inhaler development programs, including pre-formulation and physico-chemical characterization. In 2011, Justin joined MicroDose Therapeutx and created a differentiated role in process development. After the purchase by Teva, Justin continues leading process development, adding device manufacturing to his responsibilities, overseeing multiple manufacturing projects for the production of Phase 1 and Phase 2 clinical supplies for inhalation drug-device combinations and advising integrated drug-device development teams.

Gary is Chemical Engineer with 38 years of medical device and drug-device combination product development experience with companies such as Becton Dickinson, Philips Respironics and Teva, along with other small medical device and biotechnology companies. He has worked in positions in product development, operations and manufacturing with US and international responsibilities. His experience spans injection devices, needle safety devices, pre-filled syringes, respiratory drug delivery devices and respiratory drug-device combination products. He has implemented design control systems within FDA and ISO compliant Quality Management Systems in multiple organizations. He is currently a Director of Engineering in Teva Discovery and Product Development R&D.

17:50 Debating the challenges and solutions for PFS development and the increasing trends towards biologics

What are the biggest challenges for biologic drug products at the interface of formulation, primary packaging and applications?

How should we bridge the gaps in drug-delivery innovations to address the challenges of delivering complex biologics?

How should we maintain patient centricity to our development processes?

Dhairya Mehta is Associate Director at Shire. After receiving his MS in Aerospace Engineering, Dhairya began his career in the medical device and combination products. Over the past 15 years, Dhairya has successfully delivered a number of projects related to autoinjectors, wearable patch and infusion pumps, reconstitution kits, airway systems, implantable ophthalmic and cardiac rhythm management devices across several organizations such as Medtronic, Abbott, Amgen, Novo Nordisk. Dhairya holds the several US and international patents and other intellectual properties. Most recently, he is leading Digital Health and Device IoT efforts at Shire.

Dr. Steve Bowman joined Shire in 2015 as the Leader of the newly-formed Device Center of Excellence, in recognition of the increasing importance of devices and combination products to Shire’s continued growth. He’s now the Device Program Lead for two high-value rare disease products (Natpar/Natpara and Gattex/Revestive), responsible for all new global device development activities. Prior to joining Shire Steve was the Sr. Director of Sports Medicine R&D for Smith & Nephew, responsible for all global development of surgical implants and instruments for arthroscopic knee, shoulder and hip repair. He started his career at Johnson & Johnson, with multiple roles of increasing responsibility in R&D, Biologics Manufacturing, Project Management and Alliance Management. Steve earned a BS in Mechanical Engineering from Columbia University, and a PhD in Medical Engineering and Medical Physics from the Harvard - MIT Program of Health Sciences and Technology.

Having joined Eli Lilly in June 2015, Justin currently serves as Vice President, Drug Delivery Innovation at
Lilly’s Cambridge Innovation Center. In his current role, he is tasked to identify and develop distinct and
novel strategies and product systems for Lilly’s pipeline which cuts across diabetes, oncology, pain,
autoimmune, and Alzheimer’s disease. He is also leading efforts to establish a maker culture within Lilly
and developing new innovation and external partnership models in order to accelerate drug delivery
innovation.
Prior to joining Lilly, Justin spent 8 years at Becton Dickinson (BD) where he served in various roles
focused on identifying, developing, and commercializing drug delivery systems for the biotech, vaccine,
and pharmaceutical industries. During his time at BD he helped commercialize and launch more than 10
drug delivery systems and led efforts in defining the innovation agenda for BD’s $1bn drug delivery
portfolio.
Justin began his career Merck & Company where he spent seven years in roles of increasing
responsibility across new product development, product commercialization, and franchise management.
During his time at Merck he helped launch and commercialize 4 new drug products.
Justin holds a PhD in Bio-Organic chemistry from Clemson University and completed a research
fellowship at Harvard Medical School. He is the author of more than 35 patents and publications.

18:30 Chairman’s Closing Remarks and Close of Day One

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Dhairya Mehta is Associate Director at Shire. After receiving his MS in Aerospace Engineering, Dhairya began his career in the medical device and combination products. Over the past 15 years, Dhairya has successfully delivered a number of projects related to autoinjectors, wearable patch and infusion pumps, reconstitution kits, airway systems, implantable ophthalmic and cardiac rhythm management devices across several organizations such as Medtronic, Abbott, Amgen, Novo Nordisk. Dhairya holds the several US and international patents and other intellectual properties. Most recently, he is leading Digital Health and Device IoT efforts at Shire.

Stephen Barat, Head of Pre-Clinical and Early Clinical Development, ScynexisView Bio

Dr. Stephen A. Barat is the head of pre-clinical research and early development for Scynexis, a biotechnology company focused on the development and commercialization of novel anti-infective treatments for life-threatening infections. He is a member of Scynexis senior management team and has 20+ years of experience in global drug development and registration from large multi-national pharmaceutical companies. Externally, Dr. Barat is a member of the PQRI working group for leachable and extractable for parenteral drug products and a member of the USP expert panel for biocompatibility testing.

9:10 Keynote Address: The critical importance of recognizing the considerations, decisions and trade-offs inherent in all combination product developeent

Dr. Steve Bowman joined Shire in 2015 as the Leader of the newly-formed Device Center of Excellence, in recognition of the increasing importance of devices and combination products to Shire’s continued growth. He’s now the Device Program Lead for two high-value rare disease products (Natpar/Natpara and Gattex/Revestive), responsible for all new global device development activities. Prior to joining Shire Steve was the Sr. Director of Sports Medicine R&D for Smith & Nephew, responsible for all global development of surgical implants and instruments for arthroscopic knee, shoulder and hip repair. He started his career at Johnson & Johnson, with multiple roles of increasing responsibility in R&D, Biologics Manufacturing, Project Management and Alliance Management. Steve earned a BS in Mechanical Engineering from Columbia University, and a PhD in Medical Engineering and Medical Physics from the Harvard - MIT Program of Health Sciences and Technology.

Your product has multiple customers beyond patients - do you know all of them? How well? Are you sure? Prove it!

The saying "a chain is a s strong as its weakest link" applies to combination product development too. What's yours (likely there are many)? What are you doing to address them?

The future of combination products is bright - but are we confident we know what it will look like?

9:50 The Challenges of Platformization

MOLLY FOLLETTE STORY, PhD is Head, Global Usability Engineering and Risk Management in Sanofi’s Medical Device Development Unit. She was formerly Human Factors and Accessible Medical Technology Specialist at FDA/CDRH/ODE, where she had an appointment to the Senior Biomedical Research Service. While at FDA, she authored, with Ron Kaye, the CDRH draft (2011) and final (2016) human factors guidance documents. Dr. Story has particular expertise in universal design of products and the accessibility and usability of medical devices. Dr. Story is Co-chair of AAMI’s Human Factors Engineering Committee.

From a human factors perspective, what would it take to create a device that is a true platform which can be utilized for multiple molecules and a variety of user groups?

What effects might the choice of molecule have on design of the device?

What effects might the choice of molecule have on the user's interactions with the device?

For which users should the device be designed?

10:30 Morning Coffee Sponsored by Zeon

11:00 Leveraging Preformative Research to Inform Lifecycle Management of Combination Products for Complex Disease States

11:40 Panel Discussion: What is missing from the Human Factors studies and why is this still a prevalent issue?

Are we misunderstanding patient compliance?

Real world case-studies and considering end-user group needs - are we using the bigger picture?

How is IoT assisting in Human Factors studies and is this actually a hinderance to device interaction?

Gary Mills , Associate Director, Drug Product Development , TESARO

Stephen Barat, Head of Pre-Clinical and Early Clinical Development, ScynexisView Bio

Dr. Stephen A. Barat is the head of pre-clinical research and early development for Scynexis, a biotechnology company focused on the development and commercialization of novel anti-infective treatments for life-threatening infections. He is a member of Scynexis senior management team and has 20+ years of experience in global drug development and registration from large multi-national pharmaceutical companies. Externally, Dr. Barat is a member of the PQRI working group for leachable and extractable for parenteral drug products and a member of the USP expert panel for biocompatibility testing.

MOLLY FOLLETTE STORY, PhD is Head, Global Usability Engineering and Risk Management in Sanofi’s Medical Device Development Unit. She was formerly Human Factors and Accessible Medical Technology Specialist at FDA/CDRH/ODE, where she had an appointment to the Senior Biomedical Research Service. While at FDA, she authored, with Ron Kaye, the CDRH draft (2011) and final (2016) human factors guidance documents. Dr. Story has particular expertise in universal design of products and the accessibility and usability of medical devices. Dr. Story is Co-chair of AAMI’s Human Factors Engineering Committee.

Tieming holds his PhD in Mechanical Engineering from the Ohio State University and MBA from New York University. Currently he is Associate Director of Device Development and leading the combination devices development at Takeda. He has been working for various biotech and medical device companies in the past fifteen years and hold 10+ patents of drug delivery devices.

Formative study versus Summative study: Are both formative and summative studies required if an off-shelf product is used with certain modification?

Number of arms: How many arms need to be included in the human factor studies? IFU only, IFU + QRG or QRG only

Use Errors: How to deal with Use Errors found from Human Factor studies and what if these Use Errors can't be mitigated?

Juha Mattila is Senior Product Manager for STERIS Finn-Aqua Sterilization systems. He has Bachelor’s degree in HVAC & process engineering and Master’s degree in Business Informatics, both from Helsinki Metropolia University of Applied Sciences. He joined STERIS in 2000 and has 18 years of experience with pharmaceutical and research process equipment and applications, including several years in R&D for STERIS FINN-AQUA products and systems. He has worked with several clients in the designs and installations in Europe, North America and Asia, an active conference presenter, and contributes as author/co-author for articles in professional journals. Juha is a member of ISPE Nordic Board of Directors, PDA, and Finnish Biosafety Network.

New applications and technology developments on VHP (Vaporized Hydrogen Peroxide)

Having joined Eli Lilly in June 2015, Justin currently serves as Vice President, Drug Delivery Innovation at
Lilly’s Cambridge Innovation Center. In his current role, he is tasked to identify and develop distinct and
novel strategies and product systems for Lilly’s pipeline which cuts across diabetes, oncology, pain,
autoimmune, and Alzheimer’s disease. He is also leading efforts to establish a maker culture within Lilly
and developing new innovation and external partnership models in order to accelerate drug delivery
innovation.
Prior to joining Lilly, Justin spent 8 years at Becton Dickinson (BD) where he served in various roles
focused on identifying, developing, and commercializing drug delivery systems for the biotech, vaccine,
and pharmaceutical industries. During his time at BD he helped commercialize and launch more than 10
drug delivery systems and led efforts in defining the innovation agenda for BD’s $1bn drug delivery
portfolio.
Justin began his career Merck & Company where he spent seven years in roles of increasing
responsibility across new product development, product commercialization, and franchise management.
During his time at Merck he helped launch and commercialize 4 new drug products.
Justin holds a PhD in Bio-Organic chemistry from Clemson University and completed a research
fellowship at Harvard Medical School. He is the author of more than 35 patents and publications.

Activity and investments in connected injection systems and platforms continue to increase

Michael Song is Sr. Manager leading Device Functionality, Safety and Digital Connectivity at MedImmune, a Member of the AstraZeneca Group. In his role he oversees device functionality test method development and testing; primary container science and technology; biocompatibility; and digital connectivity for biologic products. Prior to his current role, Michael led the Device and Package Engineering team at Adello Biologics. He also have held key engineering and toxicology SME positions at Stryker and Kavlico, a member of Schneider Electric. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

17:50 Chairman’s Closing Remarks and Close of Day Two

FEATURED SPEAKERS

Dhairya Mehta is Associate Director at Shire. After receiving his MS in Aerospace Engineering, Dhairya began his career in the medical device and combination products. Over the past 15 years, Dhairya has successfully delivered a number of projects related to autoinjectors, wearable patch and infusion pumps, reconstitution kits, airway systems, implantable ophthalmic and cardiac rhythm management devices across several organizations such as Medtronic, Abbott, Amgen, Novo Nordisk. Dhairya holds the several US and international patents and other intellectual properties. Most recently, he is leading Digital Health and Device IoT efforts at Shire.

Justin Lacombe received a B.S. in Chemical Engineering from Virginia Tech and did his Ph.D. thesis research in fluid mechanics at Rutgers with post-doctoral projects with Sepracor and Albemarle. At Catalent, Justin worked on metered dose inhaler development programs, including pre-formulation and physico-chemical characterization. In 2011, Justin joined MicroDose Therapeutx and created a differentiated role in process development. After the purchase by Teva, Justin continues leading process development, adding device manufacturing to his responsibilities, overseeing multiple manufacturing projects for the production of Phase 1 and Phase 2 clinical supplies for inhalation drug-device combinations and advising integrated drug-device development teams.

Having joined Eli Lilly in June 2015, Justin currently serves as Vice President, Drug Delivery Innovation at
Lilly’s Cambridge Innovation Center. In his current role, he is tasked to identify and develop distinct and
novel strategies and product systems for Lilly’s pipeline which cuts across diabetes, oncology, pain,
autoimmune, and Alzheimer’s disease. He is also leading efforts to establish a maker culture within Lilly
and developing new innovation and external partnership models in order to accelerate drug delivery
innovation.
Prior to joining Lilly, Justin spent 8 years at Becton Dickinson (BD) where he served in various roles
focused on identifying, developing, and commercializing drug delivery systems for the biotech, vaccine,
and pharmaceutical industries. During his time at BD he helped commercialize and launch more than 10
drug delivery systems and led efforts in defining the innovation agenda for BD’s $1bn drug delivery
portfolio.
Justin began his career Merck & Company where he spent seven years in roles of increasing
responsibility across new product development, product commercialization, and franchise management.
During his time at Merck he helped launch and commercialize 4 new drug products.
Justin holds a PhD in Bio-Organic chemistry from Clemson University and completed a research
fellowship at Harvard Medical School. He is the author of more than 35 patents and publications.

Dr. Kashappa Goud Desai is working in the Department of Biopharmaceutical Product Sciences, GlaxoSmithKline, King of Prussia. He has over 10 years of industrial and post-doctoral R&D experience. He earned his BS and MS degrees in Pharmacy, respectively, from Karnatak University and Rajiv Gandhi University of Health Sciences, India. Dr. Desai earned his PhD degree in Biotechnology from Korea University, Republic of Korea.

Dr. Desai is a recipient of several internationally acclaimed awards for his original research contributions. He has published 50 articles in peer-reviewed international journals, authored one book and book chapter, and presented extensively at numerous conferences. He is serving as a reviewer for several international journals in the field of Pharmaceutical Sciences.

Michael Song is Sr. Manager leading Device Functionality, Safety and Digital Connectivity at MedImmune, a Member of the AstraZeneca Group. In his role he oversees device functionality test method development and testing; primary container science and technology; biocompatibility; and digital connectivity for biologic products. Prior to his current role, Michael led the Device and Package Engineering team at Adello Biologics. He also have held key engineering and toxicology SME positions at Stryker and Kavlico, a member of Schneider Electric. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

MOLLY FOLLETTE STORY, PhD is Head, Global Usability Engineering and Risk Management in Sanofi’s Medical Device Development Unit. She was formerly Human Factors and Accessible Medical Technology Specialist at FDA/CDRH/ODE, where she had an appointment to the Senior Biomedical Research Service. While at FDA, she authored, with Ron Kaye, the CDRH draft (2011) and final (2016) human factors guidance documents. Dr. Story has particular expertise in universal design of products and the accessibility and usability of medical devices. Dr. Story is Co-chair of AAMI’s Human Factors Engineering Committee.

Dr. Stephen A. Barat is the head of pre-clinical research and early development for Scynexis, a biotechnology company focused on the development and commercialization of novel anti-infective treatments for life-threatening infections. He is a member of Scynexis senior management team and has 20+ years of experience in global drug development and registration from large multi-national pharmaceutical companies. Externally, Dr. Barat is a member of the PQRI working group for leachable and extractable for parenteral drug products and a member of the USP expert panel for biocompatibility testing.

Adrien Tisserand

Key Account Manager, Nemera

Is Global Category Manager – Parenteral of Nemera, a world leader in design and manufacturing of drug delivery device. As Global category manager, he is responsible of Client Intellectual Property projects and Nemera standard technology offering. Prior joining Nemera in 2013, Mr Tisserand worked for Janssen in Strategic marketing in United Kingdom.

Amit Khanolkar

Director, New Product Development Quality Engineering, Janssen

Amit Khanolkar has been with Janssen, Pharmaceutical Companies of Johnson & Johnson since 2014 in the Combination Product Center of Excellence. In his current role, Amit is involved in providing leadership and oversight for New Product Development of Janssen Combination Product pipeline.Amit has a background in Medical Device and Combination Product development, with 12 years in R&D in the Medical Device and 4 years in Quality Engineering in the Pharma sector of Johnson & Johnson; where he held successive roles of increasing responsibilities in development as well as commercialization of numerous medical devices and combination products. Amit has actively collaborated across operating companies/sectors of Johnson & Johnson and provided strategic leadership in evaluating product and technology concepts in drug device combinations and convergent technologies.
Prior to Johnson & Johnson, Amit worked in materials and process development of high performance polymer materials for the pharmaceutical/medical device and semiconductor applications.
Amit holds a Master of Science degree in Polymer Engineering from the University of Akron and an MBA from University of Florida. He is a certified Design Excellence Black Belt, Process Excellence Green Belt and also has a certification in Statistical Engineering.

Annie Diorio-Blum

Principal Industrial Designer, Battelle

Chris Franzese

Lead Clinical Analyst, Matchstick

Debbie McConnell

Human Factors Lead, Battelle

Dhairya Mehta

Director of Device and Combination Products, Shire

Dhairya Mehta is Associate Director at Shire. After receiving his MS in Aerospace Engineering, Dhairya began his career in the medical device and combination products. Over the past 15 years, Dhairya has successfully delivered a number of projects related to autoinjectors, wearable patch and infusion pumps, reconstitution kits, airway systems, implantable ophthalmic and cardiac rhythm management devices across several organizations such as Medtronic, Abbott, Amgen, Novo Nordisk. Dhairya holds the several US and international patents and other intellectual properties. Most recently, he is leading Digital Health and Device IoT efforts at Shire.

Eric Caro

Key Account Manager, Schreiner Medipharm

Gary Mills

Associate Director, Drug Product Development , TESARO

Gary Henniger

Director Engineering, Teva Pharmaceuticals USA

Gary is Chemical Engineer with 38 years of medical device and drug-device combination product development experience with companies such as Becton Dickinson, Philips Respironics and Teva, along with other small medical device and biotechnology companies. He has worked in positions in product development, operations and manufacturing with US and international responsibilities. His experience spans injection devices, needle safety devices, pre-filled syringes, respiratory drug delivery devices and respiratory drug-device combination products. He has implemented design control systems within FDA and ISO compliant Quality Management Systems in multiple organizations. He is currently a Director of Engineering in Teva Discovery and Product Development R&D.

Janice Adkins

Joke Maes

Product Manager, Terumo Pharmaceutical Solutions

Juha Mattila

Senior Product Manager, STERIS FINN-AQUA

Juha Mattila is Senior Product Manager for STERIS Finn-Aqua Sterilization systems. He has Bachelor’s degree in HVAC & process engineering and Master’s degree in Business Informatics, both from Helsinki Metropolia University of Applied Sciences. He joined STERIS in 2000 and has 18 years of experience with pharmaceutical and research process equipment and applications, including several years in R&D for STERIS FINN-AQUA products and systems. He has worked with several clients in the designs and installations in Europe, North America and Asia, an active conference presenter, and contributes as author/co-author for articles in professional journals. Juha is a member of ISPE Nordic Board of Directors, PDA, and Finnish Biosafety Network.

Justin Lacombe

Senior Manager Process Development, Teva Pharmaceuticals USA

Justin Lacombe received a B.S. in Chemical Engineering from Virginia Tech and did his Ph.D. thesis research in fluid mechanics at Rutgers with post-doctoral projects with Sepracor and Albemarle. At Catalent, Justin worked on metered dose inhaler development programs, including pre-formulation and physico-chemical characterization. In 2011, Justin joined MicroDose Therapeutx and created a differentiated role in process development. After the purchase by Teva, Justin continues leading process development, adding device manufacturing to his responsibilities, overseeing multiple manufacturing projects for the production of Phase 1 and Phase 2 clinical supplies for inhalation drug-device combinations and advising integrated drug-device development teams.

Justin Wright

Global Head of Innovation, Novartis

Having joined Eli Lilly in June 2015, Justin currently serves as Vice President, Drug Delivery Innovation at
Lilly’s Cambridge Innovation Center. In his current role, he is tasked to identify and develop distinct and
novel strategies and product systems for Lilly’s pipeline which cuts across diabetes, oncology, pain,
autoimmune, and Alzheimer’s disease. He is also leading efforts to establish a maker culture within Lilly
and developing new innovation and external partnership models in order to accelerate drug delivery
innovation.
Prior to joining Lilly, Justin spent 8 years at Becton Dickinson (BD) where he served in various roles
focused on identifying, developing, and commercializing drug delivery systems for the biotech, vaccine,
and pharmaceutical industries. During his time at BD he helped commercialize and launch more than 10
drug delivery systems and led efforts in defining the innovation agenda for BD’s $1bn drug delivery
portfolio.
Justin began his career Merck & Company where he spent seven years in roles of increasing
responsibility across new product development, product commercialization, and franchise management.
During his time at Merck he helped launch and commercialize 4 new drug products.
Justin holds a PhD in Bio-Organic chemistry from Clemson University and completed a research
fellowship at Harvard Medical School. He is the author of more than 35 patents and publications.

Karen Unterman

Group Leader, Human Factors Engineering, Cambridge Consultants Ltd

Kashappa-Goud Desai

Associate Fellow, GSK

Dr. Kashappa Goud Desai is working in the Department of Biopharmaceutical Product Sciences, GlaxoSmithKline, King of Prussia. He has over 10 years of industrial and post-doctoral R&D experience. He earned his BS and MS degrees in Pharmacy, respectively, from Karnatak University and Rajiv Gandhi University of Health Sciences, India. Dr. Desai earned his PhD degree in Biotechnology from Korea University, Republic of Korea.

Dr. Desai is a recipient of several internationally acclaimed awards for his original research contributions. He has published 50 articles in peer-reviewed international journals, authored one book and book chapter, and presented extensively at numerous conferences. He is serving as a reviewer for several international journals in the field of Pharmaceutical Sciences.

Melanie Turieo

Director, Human Factors Engineering, Cambridge Consultants Ltd

Michael Song

Sr. Manager, Drug Delivery and Device Development, MedImmune Inc

Michael Song is Sr. Manager leading Device Functionality, Safety and Digital Connectivity at MedImmune, a Member of the AstraZeneca Group. In his role he oversees device functionality test method development and testing; primary container science and technology; biocompatibility; and digital connectivity for biologic products. Prior to his current role, Michael led the Device and Package Engineering team at Adello Biologics. He also have held key engineering and toxicology SME positions at Stryker and Kavlico, a member of Schneider Electric. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

Molly Story

MOLLY FOLLETTE STORY, PhD is Head, Global Usability Engineering and Risk Management in Sanofi’s Medical Device Development Unit. She was formerly Human Factors and Accessible Medical Technology Specialist at FDA/CDRH/ODE, where she had an appointment to the Senior Biomedical Research Service. While at FDA, she authored, with Ron Kaye, the CDRH draft (2011) and final (2016) human factors guidance documents. Dr. Story has particular expertise in universal design of products and the accessibility and usability of medical devices. Dr. Story is Co-chair of AAMI’s Human Factors Engineering Committee.

Nathan Heacock

Associate Scientist, GSK

Nathan earned his BS in Chemistry and Biochemistry from West Chester University in 2015. He started at GlaxoSmithKline as a contract worker with PPD in 2015. After significant contributions to the Syringe Second source stability study he was hired full time as an Associate Scientist in the BioPharm Product Science department of GSK in 2016.

Shota Arakawa

Researcher , Mitsubishi Gas Chemical America Inc

Mr. Shota Arakawa is a researcher of Advanced Business Development Division.
He gained a Diploma in Science in 2007 and a Master Degree of Science in 2009 from Osaka University.
Since April 2009 he has been working for Mitsubishi Gas Chemical Company, Inc.
and in charge of macromolecular science, especially in synthesis of polymers and material development.
Since 2012 he has joined a development team of multilayer plastic vial & syringe for biologics.

Stephen Barat

Head of Pre-Clinical and Early Clinical Development, Scynexis

Dr. Stephen A. Barat is the head of pre-clinical research and early development for Scynexis, a biotechnology company focused on the development and commercialization of novel anti-infective treatments for life-threatening infections. He is a member of Scynexis senior management team and has 20+ years of experience in global drug development and registration from large multi-national pharmaceutical companies. Externally, Dr. Barat is a member of the PQRI working group for leachable and extractable for parenteral drug products and a member of the USP expert panel for biocompatibility testing.

Steve Bowman

Device Program Lead, Shire US Inc

Dr. Steve Bowman joined Shire in 2015 as the Leader of the newly-formed Device Center of Excellence, in recognition of the increasing importance of devices and combination products to Shire’s continued growth. He’s now the Device Program Lead for two high-value rare disease products (Natpar/Natpara and Gattex/Revestive), responsible for all new global device development activities. Prior to joining Shire Steve was the Sr. Director of Sports Medicine R&D for Smith & Nephew, responsible for all global development of surgical implants and instruments for arthroscopic knee, shoulder and hip repair. He started his career at Johnson & Johnson, with multiple roles of increasing responsibility in R&D, Biologics Manufacturing, Project Management and Alliance Management. Steve earned a BS in Mechanical Engineering from Columbia University, and a PhD in Medical Engineering and Medical Physics from the Harvard - MIT Program of Health Sciences and Technology.

Tieming Ruan

Associate Director of Device Development, Takeda

Tieming holds his PhD in Mechanical Engineering from the Ohio State University and MBA from New York University. Currently he is Associate Director of Device Development and leading the combination devices development at Takeda. He has been working for various biotech and medical device companies in the past fifteen years and hold 10+ patents of drug delivery devices.

Toshiro Katayama

Product Manager, Zeon Chemicals L.P.

Toshiro Katayama is the product manager, at Zeon Specialty Materials Inc and responsible in development of Cyclic Olefin Polymer business in the USA. He has over 35 years of various commercial experience, general management, sales and market management, strategic planning, merger and acquisition and purchasing at Gets Bros. & Co Inc (Marmon Group), Union Carbide Corp and Itoh-Chu. He holds Bachelor of Science degree in Mechanical Engineering and Master of Science degree in Structural Engineering from Polytechnic Institute of Brooklyn.

Sponsors and Exhibitors

View detailsAptar PharmaSponsors and Exhibitorshttp://www.aptar.com/pharmaAptar Pharma is a leading provider of innovative drug delivery systems to pharmaceutical, consumer healthcare and biotech customers worldwide, enabling safe, convenient and compliant medication delivery. Trusted partner of the pharmaceutical community, we provide our customers with a large range of specialized drug delivery devices, components and analytical services backed by decades of proven expertise. We have broad therapeutic expertise in Nasal, Pulmonary, Injectables, Eye Care and Dermal delivery routes, among others. Our global manufacturing footprint of sites in Argentina, China, France, Germany, India, Switzerland and the U.S. provides security of supply and local support to our customers. For more information visit: www.aptar.com/pharma

View detailsBDSponsors and Exhibitorshttp://www.bdpharmaceuticalsystems.comBD is a medical technology company that serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. BD designs, manufactures and sells a broad range of medical supplies, devices, laboratory equipment and diagnostic products.
BD Medical - Pharmaceutical Systems is the partner of choice for the pharmaceutical industry. With innovative prefillable syringes, self-injection systems, safety systems and needle technologies, we offer an extensive selection of solutions designed to protect, package and deliver drug therapies. Our products reflect more than a century of experience and market knowledge, and our experts provide comprehensive system-based service and full product solutions.

View detailsMitsubishi Gas ChemicalSponsors and Exhibitorshttp://www.mgc.co.jp/Mitsubishi Gas Chemical is a leading company in the field of oxygen barrier and absorbing technologies. Based on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe having excellent oxygen and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs.

View detailsNemeraSponsors and Exhibitorshttp://www.nemera.netNEMERA is a world leader in the design, development and manufacturing of drug delivery solutions for pharmaceutical, biotechnology and generics industries. Nemera’s expertise covers several modes of delivery: Parenteral, Nasal, Buccal, Auricular, Ophthalmic, Pulmonary, Dermal and Transdermal.
Nemera leverages decades of experience in the parenteral device segment from full development to pure contract manufacturing, through customized solutions.
Nemera developed: Safe’n’Sound®, a fully passive safety device for prefilled syringes to avoid accidental needle-sticks. Safelia®, a new generation of 2-steps auto-injector for fluid and viscous formulations.

View detailsOwen Mumford Sponsors and Exhibitorshttp://omdevicesolutions.comOwen Mumford offer an integrated design and build service from a broad base of proven self-injection and blood-sampling platform devices and intellectual property. Find out more at omdevicesolutions.com or contact us at devicesolutions@owenmumford.co.uk

View detailsPlastic IngenuitySponsors and Exhibitorshttp://www.plasticingenuity.comPlastic Ingenuity is a custom thermoformer that provides packaging for the drug delivery and pharmaceutical markets. We specialize in creating secondary packaging for pharmaceutical combination products and automation trays that integrate into high volume assembly equipment for our drug delivery partners. These parts run flawlessly on highly complex automated equipment.

View detailsSchreiner MediPharm Sponsors and Exhibitorshttp://www.schreiner-medipharm.comSchreiner MediPharm is a leader in the development and manufacture of innovative specialty labels with value-added benefits for the pharmaceutical industry. The product portfolio includes labels with integrated hangers, with detachable parts and multi-page labels. Additionally, the company offers syringe labels with integrated needle protection, anti-tampering and counterfeiting protection solutions as well as NFC/RFID labels. These products simplify dispensing and administering of pharmaceuticals, enhance drug safety and clearly reduce process costs. Thanks to its strong solutions expertise and specialized know-how Schreiner MediPharm has established itself worldwide as a highly capable development partner and reliable quality supplier to leading pharmaceutical companies.

View detailsSTERISSponsors and Exhibitorshttp://www.sterislifesciences.comFor over 100 years STERIS Corporation has been known as a global leader, trusted partner and solutions provider in the field of sterilization and contamination control. From Formulated Chemistries, to Capital Equipment to Parts and Services, STERIS Life Sciences is Science and Solutions for Life.

View detailsSuttons CreekSponsors and Exhibitorshttp://www.suttonscreek.comSuttons Creek is your device team. Instantly leverage our experience on over 40 drug delivery systems, including pre-filled syringes (PFSs), lyophilized reconstitution kits (Lyo-kits), autoinjectors (AIs), inhalers, and on-body devices. Drastically reduce your development time and your regulatory, quality, development, and business risk by leveraging our Forge Development Process. Ask how we can support your device program or add to the capability of your organization.

Official Media Partner

View detailsAmerican Pharmaceutical ReviewOfficial Media Partnerhttp://www.americanpharmaceuticalreview.comStart receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy

View detailsColorado BioscienceOfficial Media Partnerhttp://www.cobioscience.com/As champions for life science in our state, Colorado BioScience Association leads expansion policies to advance the industry and accelerate growth. We support a thriving bioscience sector by connecting innovators to funding, infrastructure, research and talent. CBSA fosters bioscience workforce and leadership development through opportunities for networking and professional education.

View detailsONdrugDelivery MagazineOfficial Media Partnerhttp://ondrugdelivery.comONdrugDelivery Magazine is the highly regarded, world-leading series of sponsored themed drug delivery publications. Uniquely, each issue focuses tightly on one topic within the field of drug delivery. With a truly global readership already in excess of 40,000, and with contributions and loyal support from many of the most important companies in the drug delivery business - from among the largest to the smallest - ONdrugDelivery Magazine is a must for those in the industry who need to know what's going on in drug delivery.

Supporters

View detailsAbsaveSupportershttp://www.absave.comAbsave.com is the leading savings website for Antibodies and Immunological Products. Search our extensive database of Antibodies, Kits, Proteins & Peptides, Reagents, etc. to find the best savings!

View detailsAmerican LaboratorySupportershttp://www.americanlaboratory.comFor laboratory managers and researchers utilizing analytical chemistry and its applications, seeking knowledge on new technologies, methods, applications, and products, the American Laboratory® publication platform provides comprehensive technology coverage for laboratory professionals at all stages of their careers. Unlike single-channel publications, American Laboratory® is a multidisciplinary resource that engages scientists through print, digital, mobile, multimedia, and social channels to provide practical information and solutions for cutting-edge results. American Laboratory® serves the need of global community of laboratory professionals for communicating relevant technical advances and insights. Globally, American Laboratory® reaches out to subscribers by offering digital distribution plus premium print in North America. Digital communications utilize internet, mobile and social channels.

View detailsBiocompareSupportershttp://www.biocompare.comBiocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.

View detailsBiosaveSupportershttp://www.Biosave.comBiosave.com brings together the best Life Science promotions, product releases, featured products, publications, videos and events from 100’s of leading Life Science suppliers. Updated 24 hours a day, Biosave is constantly uploading special promotions and exciting product news that you won’t find anywhere else. Our goal is to provide our users with the most exclusive product information to help reach that all important purchasing decision.

View detailsDrug Development TechnologySupportershttp://www.drugdevelopment-technology.comDrugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval.
Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.

View detailsDrug Discovery TodaySupportershttp://www.drugdiscoverytoday.com/Drug Discovery Today is one of the most cited review journals in the field of drug discovery, with an impact factor of 6.422.Drug Discovery Today will benefit your research by helping to keep you up-to-date with all of the fast-moving and emerging topics in drug discovery. Each issue is packed full of the latest research news, peer-reviewed articles and comment and opinion from leading research scientists.

View detailsDrug Target ReviewSupportershttp://www.drugtargetreview.comDrug Target Review’s quarterly magazine, website and annual events program provides high quality content with peer-written articles that are submitted exclusively by the world’s most respected scientists in their field. This attracts a committed base of readers, users and delegates made up of senior decision-makers from the life science and drug discovery industries at the top pharmaceutical companies, as well as academics and scientists from the top research institutes across the globe.

View detailsGate2BiotechSupportershttp://www.gate2biotech.comGate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.

View detailsGBISupportershttp://www.gbihealth.com/GBI is an information, applications, and services company focused on the healthcare industry. Leveraging data from across the healthcare value chain, GBI creates web and mobile applications that enable individuals and organizations to make better decisions and communicate more effectively.

View detailsInderscience PublishersSupportershttp://www.inderscience.comInderscience is a dynamic, leading, independent journal publisher. The company disseminates the latest research across the broad fields of science, engineering and technology; management, public and business administration; environment, ecological economics and sustainable development; computing, ICT and internet/web services, and related areas. Inderscience offers over 35 years' experience in publishing and has succeeded in building a substantial collection approaching 400 high-quality peer-reviewed international research journals in both online and print formats. We offer a variety of ways to keep up-to-date with the latest published leading-edge research while our online collection represents a fully-searchable digital archive of around 60,000 articles.

View detailsInderscience PublishersSupportershttp://www.inderscience.comInderscience is a dynamic, leading, independent journal publisher. The company disseminates the latest research across the broad fields of science, engineering and technology; management, public and business administration; environment, ecological economics and sustainable development; computing, ICT and internet/web services, and related areas. Inderscience offers over 35 years' experience in publishing and has succeeded in building a substantial collection approaching 400 high-quality peer-reviewed international research journals in both online and print formats. We offer a variety of ways to keep up-to-date with the latest published leading-edge research while our online collection represents a fully-searchable digital archive of around 60,000 articles.

View detailsInternational Pharmaceutical IndustrySupportershttp://www.ipimediaworld.com IPI gives you an insight into all areas of Biopharm, Medical, Pharmaceutical and Healthcare. IPI provides a proven supportive means of communication to the Pharmaceutical, Bio Pharmaceutical, Nutraceutical and Medical Devices industry, incorporating the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies.

View detailsLabsaveSupportershttp://www.labsave.comLabsave is the leading savings website for Laboratory Equipment and Lab Supplies. We work closely with the top suppliers in the world to bring you the best products at the most competitive prices. We are constantly striving to secure the biggest and most exclusive offers that you won’t find anywhere else! http://www.labsave.com/

View detailsManufacturing Chemist Supportershttp://www.manufacturingchemist.comManufacturing Chemist is among the longest established and most respected information sources in the global pharmaceutical manufacturing industry.
Manufacturing Chemist reports on current and future trends in the global marketplace, including the latest developments in drug discovery, biotechnology, drug delivery, ingredients, processing technologies and equipment, packaging, business strategies and regulatory updates.

View detailsMedical Device NetworkSupportershttp://www.medicaldevice-network.com/Medicaldevice-network.com is your one stop for information on the medical device industry, covering everything along the supply chain from biomaterials and materials solutions to electronics, packaging, motors and motion control, outsourcing and more. Through our international team of journalists, we cover diagnosis, prevention, monitoring, standards, treatment and technology – all you need as a professional in the medical industry to stay abreast of the latest developments in your field.

View detailsPharma Marketing NewsSupportershttp://www.news.pharma-mkting.com/Pharma Marketing News is an independent monthly electronic newsletter focused on issues of importance to pharmaceutical marketing executives. It is a service of the Pharma Marketing Network -- The First Forum for Pharmaceutical Marketing Experts -- which brings together pharmaceutical marketing professionals from manufacturers, communications companies, and marketing service providers for wide ranging discussions and education on a multitude of current topics. Pharma Marketing Network & Pharma Marketing News provide executive-level content coupled with permission-based e-marketing opportunities.

View detailsPharmaceutical OutsourcingSupportershttp://www.pharmoutsourcing.comPharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.

View detailsPharmaceutical TechnologySupportershttp://www.pharmaceutical-technology.comPharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.

View detailsPharmacircleSupportershttp://www.pharmacircle.comPharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….

View detailsPharmalicensingSupportershttp://www.pharmalicensing.comPharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide.
Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique Partnering Search service and its global network of industry experts to enable companies to identify and engage with appropriate partners around the world.
Pharmalicensing, and its sister service Medical Device Licensing (www.medicaldevicelicensingcom) are actively utilized by over 200,000 industry professionals each month. Pharmalicensing is a division of IP Technology Exchange, Inc.

View detailsPharmaVOICESupportershttp://www.pharmavoice.comPharmaVOICE magazine, and its supporting VIEW publications, provide commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE's more than 41,000 U.S.-based subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers.

View detailsPharmiwebSupportershttp://www.pharmiweb.comEstablished in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.

View detailsSelect ScienceSupportershttp://www.selectscience.net/SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover impartial, expert opinion and trusted reviews about latest laboratory equipment and techniques; plus videos, application notes and science news from around the world. Become a member for free today.

View detailsSwiss Biotech AssociationSupportershttp://www.swissbiotech.org/The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.

View detailsTechnology NetworksSupportershttp://go.technologynetworks.com/subscribe-to-newslettersFounded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com

Workshop

VENUE

Sheraton Boston Hotel

39 Dalton Street, Boston, MA, USA

Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.

[ATTENDEE LIST] - By Company PFS East Coast 2017

[Programme] - Pre-Filled Syringes Europe 2018

[Interview] - Terumo Corporation

Sponsors and Exhibitors

Aptar Pharma

Aptar Pharma is a leading provider of innovative drug delivery systems to pharmaceutical, consumer healthcare and biotech customers worldwide, enabling safe, convenient and compliant medication delivery. Trusted partner of the pharmaceutical community, we provide our customers with a large range of specialized drug delivery devices, components and analytical services backed by decades of proven expertise. We have broad therapeutic expertise in Nasal, Pulmonary, Injectables, Eye Care and Dermal delivery routes, among others. Our global manufacturing footprint of sites in Argentina, China, France, Germany, India, Switzerland and the U.S. provides security of supply and local support to our customers. For more information visit: www.aptar.com/pharma

BD

BD is a medical technology company that serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. BD designs, manufactures and sells a broad range of medical supplies, devices, laboratory equipment and diagnostic products.
BD Medical - Pharmaceutical Systems is the partner of choice for the pharmaceutical industry. With innovative prefillable syringes, self-injection systems, safety systems and needle technologies, we offer an extensive selection of solutions designed to protect, package and deliver drug therapies. Our products reflect more than a century of experience and market knowledge, and our experts provide comprehensive system-based service and full product solutions.

Mitsubishi Gas Chemical

Mitsubishi Gas Chemical is a leading company in the field of oxygen barrier and absorbing technologies. Based on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe having excellent oxygen and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs.

Nemera

NEMERA is a world leader in the design, development and manufacturing of drug delivery solutions for pharmaceutical, biotechnology and generics industries. Nemera’s expertise covers several modes of delivery: Parenteral, Nasal, Buccal, Auricular, Ophthalmic, Pulmonary, Dermal and Transdermal.
Nemera leverages decades of experience in the parenteral device segment from full development to pure contract manufacturing, through customized solutions.
Nemera developed: Safe’n’Sound®, a fully passive safety device for prefilled syringes to avoid accidental needle-sticks. Safelia®, a new generation of 2-steps auto-injector for fluid and viscous formulations.

Owen Mumford

Owen Mumford offer an integrated design and build service from a broad base of proven self-injection and blood-sampling platform devices and intellectual property. Find out more at omdevicesolutions.com or contact us at devicesolutions@owenmumford.co.uk

Plastic Ingenuity

Plastic Ingenuity is a custom thermoformer that provides packaging for the drug delivery and pharmaceutical markets. We specialize in creating secondary packaging for pharmaceutical combination products and automation trays that integrate into high volume assembly equipment for our drug delivery partners. These parts run flawlessly on highly complex automated equipment.

Schreiner MediPharm

Schreiner MediPharm is a leader in the development and manufacture of innovative specialty labels with value-added benefits for the pharmaceutical industry. The product portfolio includes labels with integrated hangers, with detachable parts and multi-page labels. Additionally, the company offers syringe labels with integrated needle protection, anti-tampering and counterfeiting protection solutions as well as NFC/RFID labels. These products simplify dispensing and administering of pharmaceuticals, enhance drug safety and clearly reduce process costs. Thanks to its strong solutions expertise and specialized know-how Schreiner MediPharm has established itself worldwide as a highly capable development partner and reliable quality supplier to leading pharmaceutical companies.

STERIS

For over 100 years STERIS Corporation has been known as a global leader, trusted partner and solutions provider in the field of sterilization and contamination control. From Formulated Chemistries, to Capital Equipment to Parts and Services, STERIS Life Sciences is Science and Solutions for Life.

Suttons Creek

Suttons Creek is your device team. Instantly leverage our experience on over 40 drug delivery systems, including pre-filled syringes (PFSs), lyophilized reconstitution kits (Lyo-kits), autoinjectors (AIs), inhalers, and on-body devices. Drastically reduce your development time and your regulatory, quality, development, and business risk by leveraging our Forge Development Process. Ask how we can support your device program or add to the capability of your organization.

Media Partners

ONdrugDelivery Magazine

ONdrugDelivery Magazine is the highly regarded, world-leading series of sponsored themed drug delivery publications. Uniquely, each issue focuses tightly on one topic within the field of drug delivery. With a truly global readership already in excess of 40,000, and with contributions and loyal support from many of the most important companies in the drug delivery business - from among the largest to the smallest - ONdrugDelivery Magazine is a must for those in the industry who need to know what's going on in drug delivery.

American Pharmaceutical Review

Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy

Colorado Bioscience

As champions for life science in our state, Colorado BioScience Association leads expansion policies to advance the industry and accelerate growth. We support a thriving bioscience sector by connecting innovators to funding, infrastructure, research and talent. CBSA fosters bioscience workforce and leadership development through opportunities for networking and professional education.

Media Partners

Pharma Marketing News

Pharma Marketing News is an independent monthly electronic newsletter focused on issues of importance to pharmaceutical marketing executives. It is a service of the Pharma Marketing Network -- The First Forum for Pharmaceutical Marketing Experts -- which brings together pharmaceutical marketing professionals from manufacturers, communications companies, and marketing service providers for wide ranging discussions and education on a multitude of current topics. Pharma Marketing Network & Pharma Marketing News provide executive-level content coupled with permission-based e-marketing opportunities.

Select Science

SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover impartial, expert opinion and trusted reviews about latest laboratory equipment and techniques; plus videos, application notes and science news from around the world. Become a member for free today.

Swiss Biotech Association

The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.

Pharmalicensing

Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide.
Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique Partnering Search service and its global network of industry experts to enable companies to identify and engage with appropriate partners around the world.
Pharmalicensing, and its sister service Medical Device Licensing (www.medicaldevicelicensingcom) are actively utilized by over 200,000 industry professionals each month. Pharmalicensing is a division of IP Technology Exchange, Inc.

Biosave

Biosave.com brings together the best Life Science promotions, product releases, featured products, publications, videos and events from 100’s of leading Life Science suppliers. Updated 24 hours a day, Biosave is constantly uploading special promotions and exciting product news that you won’t find anywhere else. Our goal is to provide our users with the most exclusive product information to help reach that all important purchasing decision.

PharmaVOICE

PharmaVOICE magazine, and its supporting VIEW publications, provide commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE's more than 41,000 U.S.-based subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers.

Pharmaceutical Technology

Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.

Inderscience Publishers

Inderscience is a dynamic, leading, independent journal publisher. The company disseminates the latest research across the broad fields of science, engineering and technology; management, public and business administration; environment, ecological economics and sustainable development; computing, ICT and internet/web services, and related areas. Inderscience offers over 35 years' experience in publishing and has succeeded in building a substantial collection approaching 400 high-quality peer-reviewed international research journals in both online and print formats. We offer a variety of ways to keep up-to-date with the latest published leading-edge research while our online collection represents a fully-searchable digital archive of around 60,000 articles.

Biocompare

Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.

Drug Target Review

Drug Target Review’s quarterly magazine, website and annual events program provides high quality content with peer-written articles that are submitted exclusively by the world’s most respected scientists in their field. This attracts a committed base of readers, users and delegates made up of senior decision-makers from the life science and drug discovery industries at the top pharmaceutical companies, as well as academics and scientists from the top research institutes across the globe.

GBI

GBI is an information, applications, and services company focused on the healthcare industry. Leveraging data from across the healthcare value chain, GBI creates web and mobile applications that enable individuals and organizations to make better decisions and communicate more effectively.

Pharmaceutical Outsourcing

Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.

Gate2Biotech

Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.

Medical Device Network

Medicaldevice-network.com is your one stop for information on the medical device industry, covering everything along the supply chain from biomaterials and materials solutions to electronics, packaging, motors and motion control, outsourcing and more. Through our international team of journalists, we cover diagnosis, prevention, monitoring, standards, treatment and technology – all you need as a professional in the medical industry to stay abreast of the latest developments in your field.

Pharmiweb

Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.

Drug Discovery Today

Drug Discovery Today is one of the most cited review journals in the field of drug discovery, with an impact factor of 6.422.Drug Discovery Today will benefit your research by helping to keep you up-to-date with all of the fast-moving and emerging topics in drug discovery. Each issue is packed full of the latest research news, peer-reviewed articles and comment and opinion from leading research scientists.

Drug Development Technology

Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval.
Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.

Inderscience Publishers

Inderscience is a dynamic, leading, independent journal publisher. The company disseminates the latest research across the broad fields of science, engineering and technology; management, public and business administration; environment, ecological economics and sustainable development; computing, ICT and internet/web services, and related areas. Inderscience offers over 35 years' experience in publishing and has succeeded in building a substantial collection approaching 400 high-quality peer-reviewed international research journals in both online and print formats. We offer a variety of ways to keep up-to-date with the latest published leading-edge research while our online collection represents a fully-searchable digital archive of around 60,000 articles.

MedTube

Manufacturing Chemist

Manufacturing Chemist is among the longest established and most respected information sources in the global pharmaceutical manufacturing industry.
Manufacturing Chemist reports on current and future trends in the global marketplace, including the latest developments in drug discovery, biotechnology, drug delivery, ingredients, processing technologies and equipment, packaging, business strategies and regulatory updates.

International Pharmaceutical Industry

IPI gives you an insight into all areas of Biopharm, Medical, Pharmaceutical and Healthcare. IPI provides a proven supportive means of communication to the Pharmaceutical, Bio Pharmaceutical, Nutraceutical and Medical Devices industry, incorporating the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies.

Technology Networks

Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com

American Laboratory

For laboratory managers and researchers utilizing analytical chemistry and its applications, seeking knowledge on new technologies, methods, applications, and products, the American Laboratory® publication platform provides comprehensive technology coverage for laboratory professionals at all stages of their careers. Unlike single-channel publications, American Laboratory® is a multidisciplinary resource that engages scientists through print, digital, mobile, multimedia, and social channels to provide practical information and solutions for cutting-edge results. American Laboratory® serves the need of global community of laboratory professionals for communicating relevant technical advances and insights. Globally, American Laboratory® reaches out to subscribers by offering digital distribution plus premium print in North America. Digital communications utilize internet, mobile and social channels.

Labsave

Labsave is the leading savings website for Laboratory Equipment and Lab Supplies. We work closely with the top suppliers in the world to bring you the best products at the most competitive prices. We are constantly striving to secure the biggest and most exclusive offers that you won’t find anywhere else! http://www.labsave.com/

SAVE TO

Sheraton Boston Hotel

39 Dalton Street
Boston 02199
USA

Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy,
which maintains that in order to be effective, learning should be organised and
structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional
competence’

CPD is a common requirement of individual membership with professional bodies and
Institutes. Increasingly, employers also expect their staff to undertake regular
CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do
not become obsolete, and allows for best practice and professional standards to
be upheld.

CPD can be undertaken through a variety of learning activities including instructor
led training courses, seminars and conferences, e:learning modules or structured
reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with
a collective membership of circa 4 million professionals, and they all expect their
members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked
to a licence to practice, for others it’s obligatory. By ensuring that their members
undertake CPD, the professional bodies seek to ensure that professional standards,
legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide
online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’
or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve
within a given time period. These schemes can also use different ‘currencies’ such
as points, merits, units or credits, where an individual must accumulate the number
required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of
learning.

‘Output’ based schemes are learner centred. They require individuals to set learning
goals that align to professional competencies, or personal development objectives.
These schemes also list different ways to achieve the learning goals e.g. training
courses, seminars or e:learning, which enables an individual to complete their CPD
through their preferred mode of learning.

As a formal provider of CPD certified activities, SMI Group can provide an indication
of the learning benefit gained and the typical completion. However, it is ultimately
the responsibility of the delegate to evaluate their learning, and record it correctly
in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces
and looking to the UK to benchmark educational standards. The undertaking of CPD
is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk